Icotinib as Adjuvant Treatment for Stage II-IIIA Lung Adenocarcinoma Patients with EGFR Mutation (ICWIP Study): Study Protocol for a Randomised Controlled Trial
机构:[1]Department of Medical Oncology, Beijing KeyLaboratory of Clinical Study on Anticancer MolecularTargeted Drugs, National Cancer Center/NationalClinical Research Center for Cancer/Cancer Hospital,Chinese Academy of Medical Sciences & Peking UnionMedical College, Beijing, People’s Republic of China[2]Department of General Thoracic Surgery, China-JapanFriendship Hospital, Beijing, People’s Republic of China[3]Department of Medical Oncology, Beijing Hospital,Beijing, People’s Republic of China[4]Beijing ChestHospital, Capital Medical University/BeijingTuberculosis and Thoracic Tumor Research Institute,Beijing, People’s Republic of China[5]Department ofOncology, The First Affiliated Hospital of Chinese PLAGeneral Hospital, Beijing, People’s Republic of China[6]Department of Oncology, Chinese PLA GeneralHospital, Beijing, People’s Republic of China[7]Department of Thoracic Surgery, The Fourth Hospitalof Hebei Medical University, Shijiazhuang, Hebei,People’s Republic of China[8]Department ofRespiratory Medicine, The Fourth Hospital of HebeiMedical University, Shijiazhuang, Hebei, People’sRepublic of China[9]Department of RespiratoryMedicine, Peking Union Medical College Hospital,Affiliated to Chinese Academy of Medical Sciences &Peking Union Medical College, Beijing, People’sRepublic of China[10]Department of Thoracic Surgery,Peking University People’s Hospital, Beijing, People’sRepublic of China[11]Department of Thoracic Surgery,Beijing Chaoyang Hospital Affiliated to Capital MedicalUniversity, Beijing, People’s Republic of China[12]Department of Radiotherapy and Chemotherapy,Tangshan People’s Hospital, Tangshan, Hebei, People’s Republic of China[13]Department of Thoracic Surgery,Xuanwu Hospital of Capital Medical University, Beijing,People’s Republic of China外科系统胸外科首都医科大学宣武医院[14]Department of ThoracicSurgery, Peking University First Hospital, Beijing,People’s Republic of China
The efficacy and possible role of epidermal growth factor receptor tyrosine kinase inhibitors in treating early-stage non-small-cell lung cancer have yet to be established. Therefore, we aimed to explore the efficacy and safety of icotinib in completely resected EGFR-mutant stage II-IIIA lung adenocarcinoma patients who underwent standard chemotherapy. This is a randomised, double-blinded, placebo-controlled, multicentre, Phase III trial. A total of 124 patients aged 18-75 years who qualified the inclusion criteria were recruited. These patients were randomised (1:1) to receive either icotinib (125 mg 3 times per day) or placebo (the same dosage and frequency) for 36 months, followed by a further 36 months of observational window. The primary endpoint is disease-free survival (DFS), while the secondary endpoints are overall survival, 3- year and 5-year DFS, safety and tolerability of the medication, and health-related quality-of-life. Analyses will be conducted in a full analysis set and a per-protocol set as well. To our knowledge, the present study is the first randomised, double-blinded, placebo-controlled, multicenter trial designed to explore efficacy and safety of icotonib in this population. The results obtained in the near future may provide potential guidance in clinical practice.
基金:
Beijing Municipal Science and Technology Commission Major Project [D141100000214005]
第一作者机构:[1]Department of Medical Oncology, Beijing KeyLaboratory of Clinical Study on Anticancer MolecularTargeted Drugs, National Cancer Center/NationalClinical Research Center for Cancer/Cancer Hospital,Chinese Academy of Medical Sciences & Peking UnionMedical College, Beijing, People’s Republic of China
通讯作者:
通讯机构:[*1]Department of Medical Oncology,Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100021, People’s Republic of China
推荐引用方式(GB/T 7714):
Yu-Tao Liu,Xue-Zhi Hao,De-Ruo Liu,et al.Icotinib as Adjuvant Treatment for Stage II-IIIA Lung Adenocarcinoma Patients with EGFR Mutation (ICWIP Study): Study Protocol for a Randomised Controlled Trial[J].CANCER MANAGEMENT AND RESEARCH.2020,12:4633-4643.doi:10.2147/CMAR.S240275.
APA:
Yu-Tao Liu,Xue-Zhi Hao,De-Ruo Liu,Gang Cheng,Shu-Cai Zhang...&Yuan-Kai Shi.(2020).Icotinib as Adjuvant Treatment for Stage II-IIIA Lung Adenocarcinoma Patients with EGFR Mutation (ICWIP Study): Study Protocol for a Randomised Controlled Trial.CANCER MANAGEMENT AND RESEARCH,12,
MLA:
Yu-Tao Liu,et al."Icotinib as Adjuvant Treatment for Stage II-IIIA Lung Adenocarcinoma Patients with EGFR Mutation (ICWIP Study): Study Protocol for a Randomised Controlled Trial".CANCER MANAGEMENT AND RESEARCH 12.(2020):4633-4643